Medical Marijuana Quality Assurance & Regulatory Services

ARA – Avanti Rx Analytics can prepare or help you to prepare your application to become a licensed producer under the new ACMPR regulation and provide expert guidance on how to meet the security, record keeping, prepare the Quality Assurance Report (QAR), and GPP requirements, including the preparation of the Standard Operating Procedures (SOPs) and quality manual.

Our QA and Regulatory experts comprise a powerful blend of consultants with Health Canada, FDA, and industry experience including leading scientific and technical experts whose guidance and recommendation are not only scientifically and technically accurate, but also actionable.

We work with our clients to design and implement effective, efficient, and current processes that assures sustainable compliance by integration of scientific, technical, and regulatory principles.

At ARA, we work with businesses that are focused on the progress of medical marijuana industry, as against those who work solely for profit motive. Our team will help your business to achieve its goals while adhering by the laws that govern the marijuana or cannabis trade at different levels.

The consulting services offered by ARA – Avanti Rx Analytics include:

Facility Design and Process Implementation

Based on our proprietary state-of-the-art technology, we can help our clients in designing and implementing productive indoor cannabis cultivation facilities. Our years of experience and knowledge of the marijuana industry help us create optimum growth rooms for your crops and make them reach their full potential.

After identifying ideal space and surrounding area for your cultivation, we will work with you to implement an innovative crop growing facility. We can direct architectural and mechanical design as well as sourcing the suitable equipment required for successful indoor cultivation whilst meeting the compliance requirements for your licence.

Regulatory, Compliance, and Licensing

Assisting our clients to obtain their Health Canada Licence for production of medical marihuana is one of our major services that includes:

• Helping to interpret ACMPR regulations in concert with industry standards

• Preparation and submission of ACMPR application to Health Canada

• Participation in Health Canada audits of client’s facility and systems

• Evaluate and facilitate the resolution of complex exclusivity issues involving ACMPR application and related regulatory and compliance issues to ensure timely approval process

• Preparation and evaluation of written procedures, policies, and standard operating procedures (SOPs)

• Preparation of Quality Report

• Creating a program to meet current Health Canada’s expectations for GPP Compliance

• Provide expert scientific guidance to understand and resolve significant issues related to any regulatory observations and warning letters in order to ensure timely resolution of complicated scientific, technical, and/or compliance issues raised by Health Canada application reviewer.

• Develop and deliver specialized hands on trainings

• Reviewing and enhancing management controls

• Performed due diligence audits of applications in association with the ACMPR regulation

• Provide expert consultant services for development and execution of numerous remediation/voluntary corrective action plans, which have been accepted by the Health Canada

• Facilitation of a new facility construction review/s for clients with the Health Canada

Proposed List of SOPs for Medical Marijuana Producers